MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 32 SIZE M 0

Model Number	01.25.022
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by meedacta regulatory affairs department on 13 october 2020: lot 1902380: (b)(4) items manufactured and released on 13-sep-2019.Expiration date: 2024-09-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in 10 months after the primary surgery reporting instability( felt imbalanced due to unknown reasons) and the cause of the instability is unknown.The surgeon revised the crco ball head ø32 - size "m" 0 with a 28mm biolox option head and added a biolox option sleeve xl.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 32 SIZE M 0
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10741365
• Report Number: 3005180920-2020-00764
• Device Sequence Number: 11597099
• Product Code: JDI
• UDI-Device Identifier: 07630030805165
• UDI-Public: 07630030805165
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2024
• Device Model Number: 01.25.022
• Device Catalogue Number: 01.25.022
• Device Lot Number: 1902380
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention